By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative (NBBI) to accelerate biotechnology innovation and grow America’s bioeconomy across multiple sectors in industries such as health, agriculture, and energy. On December 20, 2022, the White House Office of Science and Technology Policy (OSTP) published two requests for information (RFI) related to the NBBI. In the first one, OSTP, on behalf of the primary agencies that regulate the products of biotechnology -- the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) -- requests relevant data and information, including case studies, that may assist in identifying any regulatory ambiguities, gaps, inefficiencies, or uncertainties in the Coordinated Framework for the Regulation of Biotechnology, particularly with regard to new and emerging biotechnology products. 87 Fed. Reg. 77900. According to the RFI, the information provided will inform regulatory agency efforts to improve the clarity and efficiency of the regulatory processes for biotechnology products. The RFI includes the following questions:

1. Describe any ambiguities, gaps, inefficiencies, or uncertainties regarding statutory authorities and/or agency roles, responsibilities, or processes for different biotechnology product types, particularly for product types within the responsibility of multiple agencies.
    
   1. Describe the impact, including economic impact, of these ambiguities, gaps, inefficiencies, or uncertainties.
       
2. Provide any relevant data or information, including case studies, that could inform improvement in the clarity or efficiency (including the predictability, transparency, and coordination) of the regulatory system and processes for biotechnology products.
    
3. Describe any specific topics the agencies should address in plain language on the regulatory roles, responsibilities, and processes of the agencies.
    
4. Describe any specific issues the agencies should consider in developing a plan to implement regulatory reform, including any updated or new regulations or guidance documents.

5. Describe any new or emerging biotechnology products (e.g., microbial amendments to promote plant growth; food plants expressing non-food substances or allergens from non-plant sources) that, based on lessons learned from past experiences or other information, the agencies should pay particular attention to in their evaluation of ambiguities, gaps, or uncertainties regarding statutory authorities and/or agency roles or processes.

6. Describe any new or emerging categories of biotechnology products on the horizon that the regulatory system and processes for biotechnology products should be preparing to address. Describe any specific recommendations for regulating these new or emerging categories of biotechnology products to guide agency preparations.

7. What is the highest priority issue for the agencies to address in the short term (i.e., within the next year) and in the long term.

OSTP, EPA, FDA, and USDA will host a virtual public listening session on January 12, 2023. The virtual listening session will allow OSTP, EPA, FDA, and USDA to hear, firsthand, from stakeholders who wish to provide feedback on any of the seven questions outlined in the RFI. Comments are due on or before 5 p.m. (EST) February 3, 2023. More information on the Coordinated Framework for the Regulation of Biotechnology is available in our January 9, 2017, memorandum.
 
The second RFI seeks public input on how advances in biotechnology and biomanufacturing can help achieve goals that were previously out of reach and what steps can be taken to provide the right research ecosystem, workforce, data, domestic biomanufacturing capacity, and other components to support a strong bioeconomy. 87 Fed. Reg. 77901. OSTP invites input from interested stakeholders, including industry and industry association groups; academic researchers and policy analysts; civil society and advocacy groups; individuals and organizations that work on biotechnology, biomanufacturing, or related topics; and members of the public. OSTP seeks responses to one, some, or all of the following questions:

Harnessing Biotechnology and Biomanufacturing Research and Development (R&D) to Further Societal Goals

1. For any of the four categories outlined above (health, climate and energy, food and agriculture, and supply chain resilience):
    
   1. What specific bold goals can be achieved through advances in biotechnology and biomanufacturing in the short term (five years) and long term (20 years)? In your answers, please suggest quantitative goals, along with a description of the potential impact of achieving a goal. Listed below are illustrative examples of quantitative goals:
       
      1. Develop domestic bio-based routes of production, including the entire supply chain, for X percent of active pharmaceutical ingredients.
          
      2. Utilize X tons of sustainable biomass annually as input to biomanufacturing processes to displace Y percent of U.S. petroleum consumption.
         ​
   2. What R&D is needed to achieve the bold goals outlined in (a), with a focus on cross-cutting or innovative advances? How would the government support this R&D, including through existing federal programs, creation of new areas of R&D, and/or development of new mechanisms?
       
   3. How else can the government engage with and incentivize the private sector and other organizations to achieve the goals outlined in (a)?
       
2. Public engagement and acceptance are of critical importance for successful implementation of biotechnology solutions for societal challenges. How might social, behavioral, and economic sciences contribute to understanding possible paths to success and any hurdles? What public engagement and participatory models have shown promise for increasing trust and understanding of biotechnology?

Data for the Bioeconomy

3. What data types and sources, to include genomic and multiomic information, are most critical to drive advances in health, climate, energy, food, agriculture, and biomanufacturing, as well as other bioeconomy-related R&D? What data gaps currently exist?

4. How can the federal government, in partnership with private, academic, and non-profit sectors, support a data ecosystem to drive breakthroughs for the U.S. bioeconomy? This may include technologies, software, and policies needed for data to remain high-quality, interoperable, accessible, secure, and understandable across multiple stakeholder groups.

Building a Vibrant Domestic Biomanufacturing Ecosystem

5. What is the current state of U.S. and global biomanufacturing capacity for health and industrial sectors, and what are the limits of current practice?

6. What can the federal government do to expand and scale domestic biomanufacturing capacity and infrastructure? What level of investment would be meaningful, and what incentive structures could be employed?

7. What are barriers that must be addressed to enable better domestic supply chains for biomanufacturing (e.g., feedstocks, reagents, consumables)?

8. How can the federal government partner with state and local governments to expand domestic biomanufacturing capacity, with a particular focus on underserved communities?

Biobased Products Procurement

9. What are new, environmentally sustainable biobased products that the federal government could purchase through its BioPreferred Program? How can the federal government incentivize development of new categories of sustainable biobased products?

   Biotechnology and Biomanufacturing Workforce

10. How can the U.S. strengthen and expand the biotechnology and biomanufacturing workforce to meet the needs of industry today and in the future? What role can government play at the local, state, and/or federal level?

11. What strategies and program models have shown promise for successfully diversifying access to biomanufacturing and biotechnology jobs -- including those involving Historically Black Colleges and Universities (HBCU), Tribal Colleges and Universities, and other Minority Serving Institutions? What factors have stymied progress in broadening participation in this workforce?

Reducing Risk by Advancing Biosafety and Biosecurity

12. What can the federal government do to support applied biosafety research and biosecurity innovation to reduce risk while maximizing benefit throughout the biotechnology and biomanufacturing life cycles?
     
13. How can federal agencies that fund, conduct, or sponsor life sciences research incentivize and enhance biosafety and biosecurity practices throughout the United States and international research enterprises?

 Measuring the Bioeconomy

14. What quantitative indicators, economic or otherwise, are currently used to measure the contributions of the U.S. bioeconomy? Are there new indicators that should be developed?

15. How should the North American Industry Classification System (NAICS) and the North American Product Classification System (NAPCS) be revised to enable characterization of the economic value of the U.S. bioeconomy? Specifically, which codes or categories do not distinguish between functionally identical biobased and fossil fuel-based commodities?

International Engagement

16. What are opportunities for the U.S. government to advance R&D, a skilled workforce, regulatory cooperation, and data sharing for the bioeconomy through international cooperation? Which partnerships and fora are likely keys to advance these priority areas?
     
17. What risks are associated with international biotechnology development and use, and how can the U.S. government work with allies and partners to mitigate these risks?

Comments are due on or before 5:00 p.m. (EST) on January 20, 2023.

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By Lynn L. Bergeson and Carla N. Hutton
 
On October 28, 2022, the U.S. Department of Agriculture’s (USDA) Rural Business-Cooperative Service (RBCS) and Rural Utilities Service (RUS) announced a request for information (RFI) and notice of public listening sessions on how to implement newly allocated funding opportunities under the Inflation Reduction Act (IRA). 87 Fed. Reg. 65188. It is anticipated that these funds will support new projects related to rural electric system resiliency, biofuels, renewable energy technologies, and more. USDA requests comments on specific questions in the RFI, as well as on any other topics relevant to implementation. Written comments are due November 28, 2022. USDA will also host two public listening sessions:

• November 3, 2022, focused on IRA Sections 22001, 22002, and 22003. The two-hour listening session is aimed at renewable energy generation providers, distribution utilities, transportation fueling facilities, fuel distribution facilities, environmental advocates and other environmental groups, and other federal agencies; and
   
• November 4, 2022, focused on IRA Section 22004. The two-hour listening session is aimed at electric cooperatives, environmental advocates, and other environmental groups.

Registration is required.

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By Lynn L. Bergeson

The Office of Science and Technology Policy (OSTP) published on April 4, 2022, a request for information (RFI) from interested parties on federal programs and activities in support of sustainable chemistry. 87 Fed. Reg. 19539. OSTP notes that “[t]he term “sustainable chemistry” does not have a consensus definition and most uses of the term indicate that it is synonymous with “green chemistry.”” OSTP requests information on the preferred definition for sustainable chemistry. OSTP also seeks comments on how the definition of sustainable chemistry could impact the role of technology, federal policies that may aid or hinder sustainable chemistry initiatives, future research to advance sustainable chemistry, financial and economic considerations, and federal agency efforts. OSTP states that it will use comments provided in response to the RFI to address Subtitle E of Title II of the National Defense Authorization Act (NDAA) (Subtitle E), which includes the text of the bipartisan Sustainable Chemistry Research and Development Act of 2019. Subtitle E directs OSTP “to identify research questions and priorities to promote transformational progress in improving the sustainability of the chemical sciences.” Comments are due by 5:00 p.m. (EDT) on June 3, 2022. Additional Information is available in the B&C’s April 6, 2022, memorandum.

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By Lynn L. Bergeson 

On February 1, 2022, DOE EERE BETO issued two new requests for information (RFI) on biomass conversion R&D and community organic waste programs. The RFI titled “Biomass Conversion Research, Development, and Analysis Programs” focuses on biomass conversion R&D and seeks to address improved robustness of microbial cells, catalytic processes, and state-of-technology analyses in the BETO research portfolio. Through this program, BETO is interested in receiving feedback on barriers, capabilities, tools, and other general information needed to prioritize future R&D programs in the areas of organism and catalyst development. BETO also seeks input on which analyses are most useful to the broader bioenergy research and industrial community. Responses to this RFI must be submitted by March 11, 2022, and are required to be provided as an attachment via e-mail to .(JavaScript must be enabled to view this email address).

DOE EERE BETO’s RFI titled “Community-scale Resource and Energy Recovery from Waste Solutions” requests feedback from industry, academia, research laboratories, government agencies, and other stakeholders on issues related to community programs for organic waste. DOE EERE wishes to understand better which wastes related to economic, environmental, and social impacts are of highest priority to communities and how DOE can make its Conversion R&D program more effective in addressing these types of challenges. BETO is particularly interested in input on five different waste streams: dairy manure, swine manure, food waste, municipal wastewater residuals, and fats/oils/greases. Responses to this RFI must also be submitted by March 11, 2022, and provided as an attachment via e-mail to .(JavaScript must be enabled to view this email address). In lieu of providing written responses to this RFI, BETO is also accepting requests for a 30-minute individual discussion via e-mail. Additional information on both RFIs is available here.

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By Lynn L. Bergeson 

On December 23, 2021, DOE issued a Request for Information (RFI) on the scale-up and demonstration of renewable fuels. In the RFI “Overcoming Barriers to Renewable Fuel Scale-Up and Demonstration,” DOE expresses its wish to obtain input from biofuels producers and technology developers regarding their readiness to scale process technologies to pilot- and demonstration-scale sustainable aviation fuel (SAF), renewable diesel, and renewable marine fuels. DOE also seeks feedback on how existing first-generation ethanol and other industries could be leveraged to provide low-cost feedstock and infrastructure for biofuels production. The RFI has six categories:

• Biofuel Pathway Scale-Up Forecasts;
• Barriers to Scale-Up of SAF, Marine, and Renewable Diesel Technologies;
• Leveraging First-Generation Ethanol and Other Incumbent Industries;
• BETO Scale-Up of Biotechnologies Strategy;
• Leveraging National Laboratory Professional Development Units (PDU) to Scale-Up Renewable Fuels; and
• Feedstock Production and Supply.

DOE’s Bioenergy Technologies Office (BETO) will use the information collected from this RFI to chart the potential growth of domestic renewable fuels production by 2030. BETO also wishes to understand better the existing and potential barriers that producers face in the scaling-up pathway. Responses to this RFI must be submitted on or prior to 5:00 p.m. (EST) on January 31, 2022. Additional details on how to apply can be accessed here.

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By Lynn L. Bergeson 

On August 18, 2021, DOE’s Biological and Environmental Research (BER) Program issued a request for information (RFI) seeking input on technical and logistical pathways that would enhance BER’s research portfolio in comparison to similar international research efforts. The BER Program is DOE’s coordinating office for research on biological systems, bioenergy, environmental science, and Earth system science. Written comments and information must be submitted by October 31, 2021, by e-mail only to .(JavaScript must be enabled to view this email address). The e-mail subject line should read “BER research benchmarking.”

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By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On August 12, 2020, DOE issued an RFI to obtain industry, academia, and research community input on DOE’s hydrogen and fuel cells R&D and demonstration activities and strategies, including its H2@Scale initiative. DOE hopes that feedback received will help its Hydrogen and Fuel Cell Technologies Office’s (HFTO) research priorities and goals to ensure that they address current and future needs of the hydrogen and fuel cells industry. The information will also help HFTO to guide the work being conducted through National Laboratory consortia launched to focus on challenges specific to electrolyzers and heavy-duty fuel cell applications. RFI topics include: H2@Scale; R&D priorities; near-, medium-, and long-term strategy; and approaches to foster collaboration. Responses must be submitted by 5:00 p.m. (EDT) on September 15, 2020.

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By Lynn L. Bergeson

On June 29, 2020, the United States (U.S.) Department of Energy’s (DOE) Office of Energy Efficiency and Renewable Energy (EERE) published a request for information (RFI) on challenges and opportunities in the up- and mid-stream critical materials battery supply chains. As demand for critical materials such as lithium and cobalt for the manufacturing of batteries continues to grow, DOE is seeking ways to reduce U.S. dependence on critical materials. According to DOE’s EERE, it will achieve this goal by reducing the amount of critical materials needed for battery production and recycling materials that are already in use. Consequently, the RFI is seeking input on the current state of the battery cathode materials supply chains, as well as opportunities for near-term and long-term research and development (R&D). Responses to the RFI must be submitted by July 31, 2020, and will be considered in the development of the R&D federal strategy.

DOE’s Assistant Secretary for EERE, Daniel R. Simmons, stated that “Innovation in our domestic industries and continued investment by DOE programs will help strengthen our country’s ability to manufacture and recycle these materials, and work toward more robust domestic supply chains.” His statement and the RFI itself are in response to President Donald J. Trumps’ Executive Order 13817, titled “A Federal Strategy to Ensure Secure and Reliable Supplies of Critical Minerals.”

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By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On January 30, 2020, the National Biodiesel Board (NBB) submitted comments to USDA in response to its request for information (RFI) on the Higher Blends Infrastructure Incentive Program (HBIIP). A new USDA Rural Development project, HBIIP is designed to expand the availability of domestic ethanol and biodiesel by incentivizing the expansion of sales of renewable fuels. USDA’s RFI solicited information on options for fuel ethanol and biodiesel infrastructure, innovation, products, technology, and data derived from all HBIIP processes and/or science that drive economic growth, promote health, and increase public benefit. A total of 56 comments were submitted in response to USDA’s RFI. NBB’s comments included a request for USDA to focus the program on opportunities that would invest in facilitating the greatest additional volumes of biodiesel (including bioheat and sustainable aviation fuel) to enter the marketplace. NBB also calls for direct investment in infrastructure instead of federal funding that incentivizes sales. According to NBB, infrastructure investments should include heated storage tanks, transfer stations, large-scale national retail chains, increased rail capabilities to move and store biodiesel, and pipeline terminals to blend biodiesel. Urging USDA to make HBIIP a multi-year program, NBB Vice President of Federal Affairs, Kurt Kovarik, expresses NBB’s optimism that HBIIP will facilitate biodiesel industry growth.

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By Lynn L. Bergeson

September 25, 2019, DOE EERE announced via the Federal Register a request for information (RFI) on the identification of wells of opportunity for critical geothermal field research applications. DOE’s RFI is directed to the geothermal community, seeking information about underutilized wells in known geothermal resource areas in the United States. Its aim is to obtain feedback on industry willingness to partner with DOE’s Geothermal Technologies Office (GTO) to test downhole tools, technologies, and methodologies that can improve the probability of successful geothermal commercialization. Responses to the RFI can be submitted electronically and must be received by October 25, 2019. The complete RFI document can be accessed here.

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